osteocel - nuvasive...cells osteocel contains viable mesenchymal stem cells. these bone-forming...
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An introduction to
Osteocel®
This booklet provides general information on Osteocel
cellular allografts as a bone graft substitute in your
spinal fusion surgery. It is not meant to replace any
personal conversations that you might wish to have with
your physician or other member of your healthcare team.
Not all the information here will apply to your individual
treatment or its outcome.
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About the spineThe human spine is made up of 24
bones or vertebrae in the cervical
(neck) spine, the thoracic (chest)
spine, and the lumbar (lower back)
spine, plus the sacral bones.
Vertebrae are connected by several
joints, which allow you to bend,
twist, and carry loads. The main joint
between two vertebrae is called
an intervertebral disc. The disc is
made of two parts, a tough and
fibrous outer layer (annulus fibrosis)
and a soft, gelatinous center
(nucleus pulposus). These two
parts work in conjunction to allow
the spine to move, and also provide
shock absorption.
Cervical
Thoracic
Lumbar
Sacrum
Intervertebral disc
Spinal nerves
Annulus fibrosis
Nucleus pulposus
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About the spinal cord and cauda equinaEach vertebra has an opening
(vertebral foramen) through
which a tubular nervous structure
travels. Beginning at the base
of the brain to the upper lumbar
spine, this structure is called the
spinal cord.
Below the spinal cord, in the
lumbar spine, the nerves that
exit the spinal cord continue
to travel through the vertebral
foramen as a bundle known as
the cauda equina.
At each level of the spine, spinal
nerves exit the bony spine then
extend throughout the body.
Spinal cord
Cauda equina
Vertebral foramen
Spinal cord
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What can cause pain?There are several primary causes of spine problems. The majority
of the symptoms are caused by either instability or by disc, bone,
or ligaments pressing onto the nerve roots, spinal cord, and/or
cauda equina.
What are the treatment options?Many symptoms can be treated without surgery including rest,
heat, ice, medication, injections, and physical therapy. It is important
to speak with a physician about the best option.
If symptoms do not improve with conservative treatment, physicians
may recommend spinal surgery. Surgery is reserved for those who do
not gain relief from non-operative forms of treatment, patients whose
symptoms are increasing or worsening, and/or patients that present
with a spinal condition which indicates the need for surgery.
What is spinal fusion?Fusion is a surgical procedure performed to stop motion between two
or more vertebrae by encouraging bone to form across the problem area.
In order for fusion to occur, bone graft must be applied to the surgical
site as it provides a nutrient-rich environment that promotes new bone
growth. The body heals the grafts over time, joining the vertebrae
together to form a rigid immovable column. This type of procedure
attempts to reduce back pain and other symptoms.
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Traditional bone graftingThe standard against which all bone grafts are measured is autograft or
a graft of tissue from the same patient’s body. Autograft is an effective
bone graft material because it contains all of the components necessary
for natural bone healing: living cells, signals to direct bone formation,
and structural support. However, to harvest enough bone for a fusion
procedure, a second incision is typically necessary which can lead to:
• Longer surgical procedure
• Harvest-site infection
• Prolonged recovery time
Additionally, not all patients are good candidates for autograft harvesting
due to inadequate bone quantity and/or quality.
For these reasons, a number of autograft alternatives are often used.
One common option is allograft, which is bone graft taken from a tissue
donor. However, traditional allograft materials lack living cells and thus
do not contain all of the components necessary to encourage new
bone growth.
Posterolateral Fusion Interbody Fusion
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How Osteocel technology works
Osteocel Cellular Allograft
Osteocel is a comprehensive bone graft developed to mimic your
own bone autograft. To facilitate your return to daily activities,
Osteocel provides the following bone-growing components:
Scaffold
Osteocel retains the natural scaffold, or support
structure, for new bone to grow on and through.
Signals
For bone formation to occur, specific signals are
necessary to direct the process. These signals
act on the cells within Osteocel, and help
direct your body’s own cells to stimulate
bone formation.
Cells
Osteocel contains viable mesenchymal stem
cells. These bone-forming cells are naturally
present in our bodies and are essential for bone
tissue formation and healing.
Osteocel technology preserves the live bone-forming cells in donor
tissue. These cells are not manipulated or artificially added to the
product and are specifically tested for cell viability and ability to form
bone before clinical use is approved.
Since Osteocel contains the three necessary components for bone
growth: the cells, the signals, and the scaffold, patients now have an
alternative to traditional bone graft material.
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Next Generation Bone Grafting SolutionOsteocel preserves native bone cells, making it a next generation
solution compared to traditional allograft bone-grafting materials.
Traditional allograft bone grafts do not contain viable cells and are
able to provide only the support structure for bone growth.
Clinical safety is important as you and your physician consider
bone-grafting options. Due to stringent standards required by the
U.S. Food and Drug Administration (FDA) and American Association
of Tissue Banks (AATB), reported allograft related infection rates
are much lower than those associated with the surgical procedures
themselves.1,2 Specific processing guidelines are strictly enforced:
• Tissue donors are thoroughly screened and tested to meet
or exceed safety standards mandated by the FDA and AATB.
• Tissue is cleaned and specifically processed to deplete
components that could be rejected by your body and to
retain only the elements to support bone growth.
• Each and every lot of Osteocel is meticulously tested, not only
for safety, but also to confirm the presence of active cells for
forming new bone.
Osteocel is supplied to NuVasive®, a leader in spine technology
innovation, by AlloSource®, an experienced, non-profit tissue bank
located in the United States. NuVasive and all establishments that
process Osteocel are registered with the FDA and are accredited
by AATB. These establishments do not receive donated tissue
from outside the U.S. Only tissue recovered by organ procurement
organizations, certified by AATB, are used in Osteocel processing.
Osteocel grafts have been used since 2005 as a next generation
solution for restoring quality of life.
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GlossaryAllograft: Tissue taken from one individual (the donor) and implanted
in another individual of the same species (the recipient). Allograft
tissue is regulated by the AATB and by the FDA under allograft-specific
regulations in the U.S.
Autograft: Tissue graft from the patient’s own body. Examples of
bone autograft in spine surgery include iliac crest and local bone from
the surgical site. May also be referred to as autogenous bone.
Differentiation (of cells): The process by which a less specialized cell,
which has the potential to become many cell types, becomes a more
specialized cell, with very specific functions.
Immune response: This is how your body recognizes and defends
against substances that appear foreign and harmful. Standard
laboratory tests confirm that Osteocel does not cause an immune
response. Osteocel was shown not to provoke an immune response
in a standard laboratory test.
Immunodepletion: The process used to remove all of the components
in Osteocel that have the potential to provoke an immune response.
Mesenchymal stem cells (MSCs): Cells that have the ability to
differentiate into bone, cartilage, and fat. When signaled to form
bone, MSCs differentiate into osteoprogenitor cells and then
osteoblasts, the bone-forming cells.
Osteoblasts: Cells that build bone. MSCs can differentiate
into osteoblasts.
Osteoconductive: Used to describe a graft material’s ability
to provide scaffolding for bone to grow onto.
Osteoinductive: Used to describe materials or signals that
have the potential to induce bone formation.
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Osteoprogenitor cells: Cells that are in between mesenchymal
stem cells and osteoblasts in the cell differentiation process.
Osteocel retains MSCs and osteoprogenitor cells.
Scaffold: A supporting structure that reinforces new bone formation
through cell and protein attachment. In Osteocel, the cancellous bone
matrix acts as a scaffold.
References
1. McAllister DR, Joyce MJ, Mann BJ, et al. Allograft update: The current status of tissue regulation, procurement, processing, and sterilization. Am J Sports Med 2007;35:2148-58.
2. Edwards JR, Peterson KD, Andrus ML, et al. National Healthcare Safety Network (NHSN) Report, data summary for 2006 through 2007, issued November 2008. AJIC 2008;36(9):609-26.
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Notes
Resources
For more information about Osteocel, please visit:
nuvasive.com
If you would like to learn more about patient support and education
for chronic back, leg, and neck pain sufferers and their loved ones,
please visit:
thebetterwayback.org
If you have any questions about Osteocel or spine surgery,
please call or visit your physician, who is the only one qualified to
diagnose and treat your spinal condition. This patient information
brochure is not a replacement for professional medical advice.
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To learn more about The Better Way Back, please
About The Better Way Back®
The Better Way Back is a nationwide patient support program
created by NuVasive, a leader in developing minimally invasive,
procedurally-integrated spine solutions. The Better Way Back is a
free community built on the power of empathy, and is dedicated
to providing hope, support, and information to individuals suffering
from chronic back, leg, or neck pain.
Through its Patient Ambassador Program, The Better Way Back
pairs patients considering spine surgery with patients who have
previously undergone a spine procedure. Ambassadors volunteer
their time to discuss their experiences in order to provide
additional, first-hand perspectives.
text “TBWB” to 858-360-8292
visit thebetterwayback.org
call 1-800-745-7099
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nuvasive.com
NuVasive, Inc.7475 Lusk Blvd., San Diego, CA 92121+1 800.475.9131
Osteocel
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